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Aardvark Therapeutics, Inc.
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Aardvark Therapeutics, Inc.
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SEC wrote to company
2024-11-21
Aardvark Therapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-30 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-03-25 | SEC Comment Letter | Aardvark Therapeutics, Inc. | DE | 333-294537 | Read Filing View |
| 2025-02-10 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-10 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-12-10 | SEC Comment Letter | Aardvark Therapeutics, Inc. | DE | 377-07518 | Read Filing View |
| 2024-11-21 | SEC Comment Letter | Aardvark Therapeutics, Inc. | DE | 377-07518 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-25 | SEC Comment Letter | Aardvark Therapeutics, Inc. | DE | 333-294537 | Read Filing View |
| 2024-12-10 | SEC Comment Letter | Aardvark Therapeutics, Inc. | DE | 377-07518 | Read Filing View |
| 2024-11-21 | SEC Comment Letter | Aardvark Therapeutics, Inc. | DE | 377-07518 | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-30 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-10 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-02-10 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-01-31 | Company Response | Aardvark Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-03-30 - CORRESP - Aardvark Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Aardvark Therapeutics, Inc. 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 March 30, 2026 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-0406 Attention: Chris Edwards Re: Aardvark Therapeutics, Inc. Registration Statement on Form S-3 Filed March 23, 2026 File No. 333-294537 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aardvark Therapeutics, Inc. (the “ Company ”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-3 (File No. 333-294537) of the Company, filed with the Securities and Exchange Commission on March 23, 2026 (the “ Registration Statement ”), be accelerated so that the Registration Statement shall become effective at 4:00 p.m., Eastern Time, on April 3, 2026 or as soon as possible thereafter. The Company hereby confirms that it is aware of its responsibilities under the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, as they relate to the proposed offering of the securities specified in the Registration Statement. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Samantha H. Eldredge of Paul Hastings LLP, by telephone at (650) 320-1838 or by email at samanthaeldredge@paulhastings.com. The Company hereby authorizes Ms. Eldredge to orally modify or withdraw this request for acceleration. Sincerely, AARDVARK THERAPEUTICS, INC. By: /s/ Nelson Sun Name: Nelson Sun Title: Chief Financial Officer cc: Samantha H. Eldredge, Esq. (Paul Hastings LLP)
2026-03-25 - UPLOAD - Aardvark Therapeutics, Inc. File: 333-294537
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 25, 2026 Tien-Li Lee, M.D. Chief Executive Officer Aardvark Therapeutics, Inc. 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 Re: Aardvark Therapeutics, Inc. Registration Statement on Form S-3 Filed March 23, 2026 File No. 333-294537 Dear Tien-Li Lee, M.D.: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Samantha H. Eldredge, Esq. </TEXT> </DOCUMENT>
2025-02-10 - CORRESP - Aardvark Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Aardvark Therapeutics, Inc. 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 February 10, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-0406 Attn: Eric Atallah Mary Mast Tamika Sheppard Laura Crotty Re: Aardvark Therapeutics, Inc. Registration Statement on Form S-1, as amended (File No. 333-284440) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aardvark Therapeutics, Inc. (the “Company”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-1 (File No. 333-284440) of the Company, originally filed with the Securities and Exchange Commission (the “Commission”) on January 23, 2025, as amended (the “Registration Statement”), be accelerated so that such Registration Statement shall become effective at 4:00 p.m., Eastern Time, on February 12, 2025 or as soon as possible thereafter. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Jeffrey T. Hartlin of Paul Hastings LLP, by telephone at (650) 320-1804 or by email at jeffhartlin@paulhastings.com. The Company hereby authorizes Mr. Hartlin of Paul Hastings LLP to orally modify or withdraw this request for acceleration. Sincerely, AARDVARK THERAPEUTICS, INC. By: /s/ Tien-Li Lee Name: Tien-Li Lee, M.D. Title: Chief Executive Officer cc: Jeffrey T. Hartlin, Esq. (Paul Hastings LLP)
2025-02-10 - CORRESP - Aardvark Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP February 10, 2025 United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attn: Eric Atallah Mary Mast Tamika Sheppard Laura Crotty Re: Aardvark Therapeutics, Inc. (the “Registrant”) Registration Statement on Form S-1, as amended (File No. 333-284440) Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933, as amended, we wish to advise that between February 7, 2025 and the date hereof, approximately 1,260 copies of the Preliminary Prospectus, dated February 6, 2025, were distributed to prospective underwriters, institutional investors and prospective dealers in connection with the above-captioned Registration Statement, as amended. We wish to advise you that the participating underwriters have informed us that they have complied and will continue to comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. We hereby join in the request of the Registrant that the effectiveness of the above-captioned Registration Statement, as amended, be accelerated to 4:00 p.m. Eastern Time, on Wednesday, February 12, 2025 or as soon thereafter as practicable. [signature page follows] Very truly yours, MORGAN STANLEY & CO. LLC BOFA SECURITIES, INC. CANTOR FITZGERALD & CO. RBC CAPITAL MARKETS, LLC As representatives of the Underwriters MORGAN STANLEY & CO. LLC By: /s/ Frank Tang Name: Frank Tang Title: Managing Director BOFA SECURITIES, INC. By: /s/ John Bishai Name: John Bishai Title: Managing Director CANTOR FITZGERALD & CO. By: /s/ Jason Fenton Name: Jason Fenton Title: Managing Director, Co-Head of Equity Capital Markets RBC CAPITAL MARKETS, LLC By: /s/ Greg Wiederrecht Name: Greg Wiederrecht Title: Managing Director [Signature Page to Acceleration Request Letter]
2025-01-31 - CORRESP - Aardvark Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Aardvark Therapeutics, Inc. 4370 La Jolla Village Drive, Suite 1050 San Diego, CA 92122 February 10, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549-0406 Attn: Eric Atallah Mary Mast Tamika Sheppard Laura Crotty Re: Aardvark Therapeutics, Inc. Registration Statement on Form S-1, as amended (File No. 333-284440) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Aardvark Therapeutics, Inc. (the “Company”) hereby respectfully requests that the effectiveness of the Registration Statement on Form S-1 (File No. 333-284440) of the Company, originally filed with the Securities and Exchange Commission (the “Commission”) on January 23, 2025, as amended (the “Registration Statement”), be accelerated so that such Registration Statement shall become effective at 4:00 p.m., Eastern Time, on February 12, 2025 or as soon as possible thereafter. It would be appreciated if, promptly after the Registration Statement has become effective, you would so inform our outside counsel, Jeffrey T. Hartlin of Paul Hastings LLP, by telephone at (650) 320-1804 or by email at jeffhartlin@paulhastings.com. The Company hereby authorizes Mr. Hartlin of Paul Hastings LLP to orally modify or withdraw this request for acceleration. Sincerely, AARDVARK THERAPEUTICS, INC. By: /s/ Tien-Li Lee Name: Tien-Li Lee, M.D. Title: Chief Executive Officer cc: Jeffrey T. Hartlin, Esq. (Paul Hastings LLP)
2024-12-10 - UPLOAD - Aardvark Therapeutics, Inc. File: 377-07518
December 10, 2024
Tien-Li Lee, M.D.
Chief Executive Officer
Aardvark Therapeutics, Inc.
4370 La Jolla Village Drive, Suite 1050
San Diego, CA 92122
Re:Aardvark Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted November 27, 2024
CIK No. 0001774857
Dear Tien-Li Lee M.D.:
We have reviewed your amended draft registration statement and have the following
comments.
Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, any references to prior comments are to comments in
our November 21, 2024 letter.
Draft Registration Statement on Form S-1 filed November 27, 2024
Business
Our Preclinical Data in Support of ARD-201, page 135
1.We note your response to prior comment 2. Please further revise your disclosure to
remove the following: "When administered in combination with liraglutide and
a DPP-4 inhibitor, ARD-101 outperformed the weight loss results achieved with either
liraglutide and sitagliptin individually...suggesting that a combination with ARD-
101 may have clinical benefits over either of the two drug classes alone."
December 10, 2024
Page 2
Governmental Regulations, page 144
2.We note your response to prior comment 12 and the disclosure now provided on pages
18 and 147. Please further revise your disclosure in the above-entitled section of the
prospectus to discuss the potential application of the FDA’s Combination Rule. See
21 CFR 300.50 for reference.
Please contact Eric Atallah at 202-551-3663 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeff Hartlin
2024-11-21 - UPLOAD - Aardvark Therapeutics, Inc. File: 377-07518
November 21, 2024
Tien-Li Lee, M.D.
Chief Executive Officer
Aardvark Therapeutics, Inc.
4370 La Jolla Village Drive, Suite 1050
San Diego, CA 92122
Re:Aardvark Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted October 24, 2024
CIK No. 0001774857
Dear Tien-Li Lee M.D.:
We have reviewed your draft registration statement and have the following comments.
Please respond to this letter by providing the requested information and either
submitting an amended draft registration statement or publicly filing your registration
statement on EDGAR. If you do not believe a comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing the information you provide in response to this letter and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted October 24, 2024
Prospectus Summary, page 2
1.Please provide balancing disclosure in the Prospectus Summary concerning the
following:
•your history of net losses and accumulated deficit, quantifying each;
•your ability to continue as a going concern; and
•the current competitive landscape surrounding the treatment of obesity and
obesity-related conditions, relevant to your development of ARD-201.
Please revise or remove statements both here and throughout the prospectus implying
that your product candidates are or may be determined to be safe and/or effective.
Examples of such statements include, but are not limited to, the following:2.
November 21, 2024
Page 2
•that you have "observed promising clinical benefit with an encouraging
tolerability profile";
•that you believe your product candidates can "offer enhanced efficacy, tolerability
and convenience over existing therapies to provide superior benefits to patients";
•that you have "successfully" completed certain clinical trials; and
•your statement that "ARD-201’s full potential remains to be discovered in future
trials, with enhanced potency through combination with a DPP-4 inhibitor, and
without the constraints in the Phase 2a clinical trial design".
Note that conclusions of safety and efficacy are within the sole purview of the FDA.
Given the fact that your products candidates have not yet been approved by the FDA,
it is premature to state or imply that your product candidates are safe and/or effective.
Rather than including conclusory statements, you may include information regarding
data observed in trials to date. In addition, based on the uncertainty surrounding the
timing of clinical trials, please remove your statement that you plan to pursue
"accelerated development" of ARD-101.
3.We note your statement that the administration of CCK may significantly reduce food
consumption in patients with hyperphagia associated with HO. Please cite the specific
literature mentioned as the source for this claim.
4.We note your references both here and elsewhere to a "potentially pivotal Phase 3
clinical trial" for ARD-101. We also note your statements on page 25 that you have
not previously conducted any later stage or pivotal clinical trials and that in order to
do so, you "will need to expand [y]our clinical management and regulatory
capabilities." Please provided more detail regarding the steps needed to be taken prior
to conducting this trial in each instance where the "potentially pivotal Phase 3" is
discussed.
We plan to conduct certain clinical trials for our product candidates outside the . . ., page 26
5.We note your statement that you plan to conduct certain clinical trials of ARD-101
and ARD-201 outside the U.S., including, but not limited to, in "the EU, Australia and
Asia". Please expand this disclosure to clarify the specific countries in which the
company has already conducted clinical trials, specifying the trial, and where the
company currently plans to conduct trials in the future.
An active and liquid trading market for our common stock may not develop..., page 76
6.We note your statement in the above entitled risk factor that there is no assurance that
your application to list your common stock on the Nasdaq Global Market will be
approved. We also note your statement on the cover page and pages 194 and 204 that
the offering is contingent upon obtaining approval of such listing. Please reconcile
these statements.
November 21, 2024
Page 3
Management's Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations
Comparison of the Six Months Ended June 30, 2023 and 2024
Research and Development Expenses, page 105
7.You disclose on page 3 that you are pursuing two indications for ARD-101 and one
indication for ARD-201. For each significant research and development project,
please disclose the costs incurred during each period. If the company does not track
research and development costs by individual project, please clarify in the filing.
Critical Accounting Estimates
Stock-Based Compensation Expense, page 111
8.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and
the reasons for any differences between the recent valuations of your common stock
leading up to the initial public offering and the estimated offering price. This
information will help facilitate our review of your accounting for equity issuances
including stock compensation. Please discuss with the staff how to submit your
response.
Our Strategy, page 118
9.We note your statements throughout the prospectus indicating you believe that ARD-
201 has "the potential to address the gaps associated with GLP-1 treatments", which
include weight regain post-withdrawal and the loss of lean body mass. Please revise
your disclosure to explain why you do not believe these will be issues with ARD-
201 and provide data supporting your statements.
ARD-101 Preclinical Data Summary, page 123
10.Please define "tachyphylaxis" where first used on page 123.
ARD-101, page 125
11.Please revise Figure 3 and other figures, as appropriate, to provide a clear key for the
colors used in the bar graph representations.
Government Regulations, page 136
12.Please update the disclosure in your Government Regulations section to disclose how
the regulatory framework for your fixed-dose combination of the ARD-201 product
candidate may differ from your other product candidates in development or otherwise
advise. Also, revise your risk factor disclosure to include a discussion of
any material risks arising from your development of a fixed-dose combination product
candidate.
Intellectual Property, page 136
Please revise your intellectual property disclosure to clearly describe for each material
individual or patent family the type of patent protection (e.g., composition of matter,
use or process), the product candidate(s) dependent on each patent or patent family, 13.
November 21, 2024
Page 4
the expiration dates of each patent or patent family discussed, and the jurisdiction of
each. In this regard, it may be useful to provide this disclosure in tabular form to
support the narrative already included.
Statements of Cash Flows, page F-6
14.Please explain to us why you have classified your payment made in exchange for
related party convertible promissory notes as a financing activity. Refer to ASC 230-
10-45-15.
General
15.Please supplementally provide us with copies of all written communications, as
defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so
on your behalf, present to potential investors in reliance on Section 5(d) of the
Securities Act, whether or not they retain copies of the communications.
Please contact Eric Atallah at 202-551-3663 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Tamika Sheppard at 202-551-8346 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Jeff Hartlin